FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRECTOR®
DI: 00856222004186
·
Model: 71102
·
INSIGHT INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INTRECTOR®
- Primary DI
- 00856222004186
- Version / Model
- 71102
- Catalog Number
- 71102
- Company Name
- INSIGHT INSTRUMENTS, INC.
- Labeler DUNS
- 828348391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ecf3bfaa-f427-40bb-9236-1261929c814a
Device Description
INTRECTOR® Power Unit for use with the INTRECTOR® Portable Vitrectomy System REF: 71200
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14386 | Vitrectomy system generator | A mains electricity (AC-powered) ophthalmic device that generates the energy (e.g., ultrasonic, piezoelectric, pneumatic) in a vitrectomy system. The energy is delivered through a handpiece, which converts it into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. It will typically be activated by the surgeon using a foot control and may provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. It is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856222004186 | GS1 |
Customer Contacts
- Phone
- (772) 219-9393
- [email protected]